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U.S. Food and Drug Administration Current Activities and Implementation of Regulations

July 28, 2011: Cessation: Emerging Interventions and Innovations

Corinne Husten, M.D., M.P.H., Senior Medical Advisor, Center for Tobacco Products, Food and Drug Administration

Dr. Husten began her remarks by providing background on The Family Smoking Prevention and Tobacco Control Act Tobacco Control Act that became law on June 22, 2009. The Tobacco Control Act amends the Federal Food, Drug, and Cosmetic Act to give FDA authority to regulate the manufacture, distribution, and marketing of tobacco products to protect public health. While tobacco product regulation is an important component of a comprehensive strategy, it does not replace the need for other key tobacco control strategies such as smoke-free air laws, excise tax increases, cessation services, and surveillance. The Center for Tobacco Products (CTP) regulatory authority can extend to all tobacco products. However, currently only cigarettes, roll-your-own and smokeless tobacco are under the jurisdiction of the FDA. FDA has indicated its intent to expand its jurisdiction to include all tobacco products including cigars, pipe tobacco, and new tobacco products such as e-cigarettes. Furthermore, The Tobacco Control Act directs FDA to use a public health/population health standard when regulating products and gives a broad set of sanctions for violations of the law that include warning letters, civil monetary penalties, no-tobacco sales orders, seizures, injunctions, and/or criminal prosecutions.

The scope of FDA authorities under the law:

  • Regulate tobacco products
    • Registration of tobacco manufacturers list of products; ingredient reporting; reporting of harmful and potentially harmful constituent levels by brand; pesticide level controls; establish good manufacturing practices and inspect tobacco companies; establish standards for tobacco products (harmful constituents, addiction/abuse liability, appeal); premarket review of new tobacco products; premarket review of tobacco products with modified risk claims; adverse event reporting; and tobacco industry disclosure of research on the health and dependency effects of tobacco use
  • Regulate the Advertising, Marketing and Promotion of Tobacco Products
    • The Tobacco Control Act prohibits the use of the terms "light," "low," and "mild;" prohibits false or misleading labeling and advertising for tobacco products; gives FDA pre-market review of advertising for modified risk tobacco products; prohibits tobacco sponsorship of sporting, entertainment and cultural events; prohibits the distribution of free cigarettes and restricts free smokeless sampling; prohibits non-tobacco products linked to tobacco products; and limits advertising in publications with large youth readership.
  • Regulate the Distribution and Sales of Tobacco Products
    • The Tobacco Control Act protects young people by requiring proof-of-age to purchase tobacco products (federal minimum age is 18); limits vending machines and self-service displays; and prohibits the sale of packages of less than 20 cigarettes.
  • Public Education about the Dangers of Tobacco Products/Use
    • The Tobacco Control Act requires health warnings on packaging and advertising:
      • The text for smokeless tobacco must cover at least 30 percent of the two principle display panels;
      • Graphic warnings for cigarettes must cover 50 percent of front and back;
      • For advertisements, the warning must cover at least 20 percent of the area of the ad; and
      • The 1-800-QUIT NOW number will be included on the graphic cigarette health warnings.
    • Lists of harmful and potentially harmful constituents must be made available;
    • Public education campaigns to support the provisions of the Tobacco Control Act are allowed, including CTP's "Break the Chain of Tobacco Addiction," a retailer education program to raise awareness of new regulations and encourage voluntary compliance. Additional campaigns may communicate the hazards of tobacco product use.

Dr. Husten continued by discussing some of the limits on FDA's authority to regulate tobacco products. FDA cannot ban an entire class of tobacco products; require the total elimination of nicotine from tobacco products; require prescriptions to purchase tobacco products; ban tobacco sales in any particular type of sales outlet; and regulate tobacco farming.

In a very short time the Center for Tobacco Products has achieved significant milestones which include the establishment of the office and staff recruitment; implementation of the mandated prohibition on certain fruit and candy flavored tobacco products; issued guidance for registration of domestic product industry, product listing, and ingredient listing; issued the final rule restricting access and marketing of cigarettes and smokeless tobacco products to youth; required new health warnings for smokeless tobacco products; prohibited use of terms "light," "low," and "mild" for products that do not have a modified risk marketing order; awarded 15 state enforcement contracts; enforced the action plan on advertising and promotion to youth and minority communities; proposed graphic health warning regulations for public comment; released the Tobacco Products Scientific Advisory Committee (TPSAC) report on menthol; and issued the final rule on graphic health warnings.

The next major milestones for the CTP include the report from the TPSAC on dissolvable tobacco products (March 2012); establishment of a list of harmful or potentially harmful constituents and issuing guidance or regulations on scientific evidence to use in assessing modified risk products (April 2012); and the graphic warning regulations take effect in September 2012.

Dr. Husten concluded her remarks by encouraging Committee members to submit comments on proposed rules, dockets and guidance documents through the website at Exit Notification/Disclaimer Policy

Following a ten-minute break, the Committee reconvened at 10:25 a.m. and Surgeon General Benjamin introduced the next speaker.

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